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Prospective, Randomized Study of 2 Different Wound Dressings

NCT01988818 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-05-11

No results posted yet for this study

Summary

The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:

* the performance of the dressing
* the comfort, conformability and the acceptability of the dressing
* pain before, during and after dressing removal
* the overall cost regarding dressing wear time, time to do dressing change and personal resources needed

Conditions

  • Hip-surgery
  • Knee-surgery
  • Spinal-surgery

Interventions

DEVICE

Mepilex® Border Post-Op

wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing

DEVICE

standard wound dressing

standard wound dressing after hip-knee or spinal surgery

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Jan Bredow, physician · University Hospital of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-12-31
Completion
2016-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01988818 on ClinicalTrials.gov